MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for MALE URINAL 8601-2 manufactured by Lsl Healthcare Inc.
[41758466]
An inpatient was using urinal in bathroom to urinate and scraped the head of his penis with the sharp edge of urinal. This resulted in an abrasion which bled. Pressure was applied to abrasion and bleeding stopped after about 3 minutes. Patient was on anticoagulant medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061418 |
| MDR Report Key | 5541599 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-03-22 |
| Date Added to Maude | 2016-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALE URINAL |
| Generic Name | MALE URINAL |
| Product Code | FNP |
| Date Received | 2016-03-29 |
| Model Number | 8601-2 |
| Catalog Number | 8601-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSL HEALTHCARE INC |
| Manufacturer Address | 5535 N. WOLCOTT AVE. CHICAGO IL 60640 US 60640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-29 |